SAGE Journals

Reinforce chapter themes with free access to two journal articles for each chapter and further online readings. Select chapters will also include suggested weblinks.

Journal Article 17.1: Aarabi, M. and Jackson, P. (2007) ‘Prevention of coronary heart disease with statins in UK South Asians and Caucasians’, European Journal of Cardiovascular Prevention and Rehabilitation 14: 333–9.

Discussion Points: How was the data analyzed and presented in this study?

Journal Article 17.2: Tettenborn, M., Prasad, S., Poole, L., Steer, C., Coghill, D., Harpin, V., Speight, N. and Myttas, N. (2008) ‘The provision and nature of ADHD services for children/adolescents in the UK: Results from a nationwide survey’, Clinical Child Psychology and Psychiatry 13: 287–304.

Discussion Points: Critically evaluate this paper in terms of data analysis.

Journal Article 17.3: Clark, M. D., Asken, B. M., Marshall, S. W. and Guskiewicz. K. M. (2017) ‘Descriptive characteristics of concussions in National Football League games, 2010-2011 to 2013-2014’, The American Journal of Sports Medicine 45(94): 929–36.

Description: Despite a high reported incidence rate of concussion, little is known about the on-field characteristics of injurious head impacts in National Football League (NFL) games. Purpose: To characterize on-field features (location, player position, and time during game) and biomechanical features (anticipation status, closing distance, impact location and type) associated with concussions in NFL games over a 4-season period (2010–2011 to 2013–2014). Descriptive epidemiology study. Methods: We analyzed video of a subset of reported, in-game concussions for the 2010–2011 to 2013–2014 seasons. These videos represented a sample of injuries that were diagnosed and reported on the same day and that could be clearly associated with an in-game collision as captured on video. We determined anticipation status, closing distance, impact location on the injured player’s helmet, and impact type (helmet-to-helmet, helmet-to-body, or helmet-to-ground). Associations between these variables were analyzed by use of descriptive statistics and tests of association. A total of 871 diagnosed concussions were reported as occurring during NFL preseason, regular season, and postseason games for the 2010–2011, 2011–2012, 2012–2013, and 2013–2014 seasons. A total of 1324 games were played during this period, giving a concussion incidence rate of 0.658 per game (95% CI, 0.61-0.70). From the video-reviewed subset (n = 429; 49.3%), the majority of injurious impacts occurred with good anticipation (57.3%) and <10 yards of closing distance (59.0%). An association was found between anticipation status and play type (χ 23 χ32 = 27.398, P < .001), largely because injuries occurring on pass plays were more likely to be poorly anticipated than injuries during run plays (43.0% vs 21.4%; χ 21 χ12 = 14.78, P < .001). Kick returns had the greatest proportion of well-anticipated impacts (78%) and the greatest proportion of impacts with ≥10 yards of closing distance (80%). The type of impact was approximately equally divided between helmet-to-helmet, helmet-to-body, and helmet-to-ground types. The impact location was broadly distributed over the helmet of the injured player. In-game concussions in the NFL occurred through a diverse variety of mechanisms, surprisingly tended to be well-anticipated, and, also surprisingly, occurred with <10 yards of closing distance. The impacts causing concussion were broadly distributed over the helmet. More concussions occurred during the second half of game play, but we do not have evidence to explain this finding.

Journal Article 17.4: Grady, C., Bedarida, G., Sinaii, N., Gregorio M. A. and Emanuel, E. J. (2017) ‘Motivations, enrollment decisions, and socio-demographic characteristics of healthy volunteers in phase 1 research’, Clinical Trials 14(5): 526–36.

Description: Phase 1 trials with healthy volunteers are an integral step in drug development. Commentators worry about the possible exploitation of healthy volunteers because they are assumed to be disadvantaged, marginalized, and inappropriately influenced by the offer of money for research for which they do not appreciate the inherent risks. Yet there are limited data to support or refute these concerns. This study aims to describe the socio-demographic characteristics, motivations, and enrolment decision-making of a large cohort of healthy volunteers. We used a cross-sectional anonymous survey of 1194 healthy volunteers considering enrolment in phase 1 studies at Pfizer Clinical Research Units in New Haven, CT; Brussels, Belgium; and Singapore. Descriptive statistics describe motivations and socio-demographic characteristics. Comparisons between groups were examined. The majority rated consideration of risks as more important to their enrolment decision than the amount of money, despite reporting that their primary motivation was financial. Risk, time, money, the competence and friendliness of research staff, and contributing to medical research were important factors influencing enrolment decisions for most participants. The majority of healthy volunteers in this cohort were male, single, reported higher than high school education, and 70% had previous research experience. Many reported low annual incomes (50% below US$25,000) and high rates of unemployment (33% overall). Nonetheless, risk as an important consideration, money, and other reported considerations and motivations, except for time, did not vary by income, employment, education, or previous experience. There were regional differences in both socio-demographic characteristics and factors important to participation decisions. Healthy volunteers in phase 1 studies consider risks as more important to their enrolment decisions than the amount of money offered, although most are motivated to participate by the offer of money. Healthy volunteers are indeed low income, disproportionately unemployed, and have significant prior research experience. Yet these factors do not appear to affect either their motivations for participation or factors important to their research enrolment decisions.